Accurate early-stage diagnosis of some severe diseases associated with high morbidity and mortality rates, including cancers and heart diseases, is very difficult. Existing diagnostic technologies typically depend on macro data and information, such as body temperature, blood pressure and scanned body images. Many common diagnostic instruments based on imaging technologies, including X-ray, CT scan, nuclear magnetic resonance (NMR), have been used in the detection of serious diseases such as cancers. Although these technologies can make contributions to various extents to disease detection, most of these technologies cannot achieve accurate, completely safe and low-cost early-stage diagnosis for severe diseases such as cancers. In addition, many existing diagnostic technologies and related instruments are invasive and sometimes rarely available, particularly in remote and rural areas.
Currently, detection, particularly DNA detection, of various macromolecules in biological fluids, that can provide crucial biological and pathological information, has become an important tool in regular physiological testing for identification of disease causes, pathogen analysis and genetic research.
In the field of detection of various macromolecules in biological fluids, efforts have been focused on how to perform such detection in a fast, reliable, accurate and economical manner to provide more timely biological and pathological information for the diagnosis and detection of diseases. In recent years, there have been some efforts to introduce the nano-technology to a variety of biological applications, most of which are about the gene mapping and mild disease detection. For example, some scholars have discussed the use of micro-electro-mechanical systems (MEMS) sensors in in-vitro detection of cancer cells in blood and bone marrow, and there has also been disclosed by a scholar in the United States a method of MEMS-based detection of a biological medium.
However, all such detection methods involve complex sample preparation procedures (e.g., the use of chemical or biological markers) which lead to a complicated and time-consuming detection process, making these approaches unsuitable for real-time diagnosis of serious diseases such as cancers, especially for conventional hospital screening and regular physical examination.
In order to address this issue, the present invention provides apparatuses and methods for detecting a macromolecule in a biological fluid, which employ a silicon micromachining technology to integrate a silicon sieve for the macromolecules, silicon semiconductor detectors and even a detection signal processor, and thus provide the advantages such as high integration, simple manufacturability, convenience in use, high detection and signal processing accuracy and high speed.